StemCells, Inc. Welcomes Approval of First Embryonic Stem Cell Lines Under New NIH Guidelines
PALO ALTO, Calif., December 3, 2009 – StemCells, Inc. (NASDAQ: STEM) announced today that it welcomes the approval yesterday by the National Institutes of Health (NIH) of the first 13 human embryonic stem cell (hESC) lines for use in NIH-funded research under the NIH Guidelines for Human Stem Cell Research adopted in July 2009. The guidelines implement President Obama’s executive order of March 9, 2009 permitting the federal government, through the NIH, to support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research. Stem cell research holds the potential to advance the understanding of many diseases at a fundamental, cellular level, and may open new avenues for treatments or cures. The Company considers this action by the federal government as a critical first step for the advancement of the stem cell field and for the future practice of medicine.
StemCells is focused on the development and commercialization of cell-based technologies, including technologies relating to embryonic stem cells, induced pluripotent stem (iPS) cells, and tissue-derived (adult) stem cells. In its cellular medicine product development programs, the Company is currently focused on developing tissue-derived (adult) stem cells as cell-based therapeutics. The Company’s lead product candidate, HuCNS-SC ® cells (purified human neural stem cells), is in clinical development for the treatment of two fatal neurodegenerative disorders that primarily affect young children.
Through the acquisition of the operating business of Stem Cell Sciences Plc in April of this year, StemCells added a number of proprietary assets relating to a range of stem and progenitor cell technologies, including four embryonic stem cell lines ( MEL 1 to 4), which were developed by Company scientists, cell culture media for iPS derivation, and expertise and infrastructure for providing cell-based assays for drug discovery using a variety of cell types. While not currently developing embryonic stem cells for therapeutic use, the Company is presently evaluating the many cell lines acquired from Stem Cell Sciences, including embryonic stem cells, as potential therapeutics for diseases and disorders of the central nervous system.
About StemCells, Inc.
StemCells, Inc. is focused on the development and commercialization of cell-based technologies. In its cellular medicine programs, StemCells is targeting diseases of the central nervous system and liver. StemCells’ lead product candidate, HuCNS-SC cells (purified human neural stem cells), is in clinical development for the treatment of two fatal neurodegenerative disorders that primarily affect young children. StemCells also markets specialty cell culture media products under the brand SC Proven ®, and is developing its cell-based technologies for use in drug screening and drug development. The Company has exclusive rights to approximately 55 issued or allowed U.S. patents and approximately 200 granted or allowed non-U.S. patents. Further information about StemCells is available at www.stemcellsinc.com.
Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the potential for the Company’s therapies to treat PMD, NCL and other serious neurodegenerative diseases, the potential for its cell-based therapeutics to treat other diseases or disorders, and the future business operations of the Company, including its ability to conduct clinical trials as well as its other research and product development efforts. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management’s current views and are based on certain assumptions that may or may not ultimately prove valid. The Company’s actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including uncertainty as to whether the FDA or other applicable regulatory agencies will permit the Company to continue clinical testing of proposed therapies given the novel and unproven nature of the Company’s technologies; uncertainties regarding the Company’s ability to obtain the increased capital resources needed to continue its current and planned research and development operations, including such operations of the Company for non-therapeutic applications, and to conduct the research, preclinical development and clinical trials necessary for regulatory approvals; uncertainty as to whether HuCNS-SC and any products that may be generated in the future in the Company’s cell-based programs will prove safe and clinically effective and not cause tumors or other adverse side effects; uncertainties regarding the Company’s ability to commercialize a therapeutic product and its ability to successfully compete with other products on the market; uncertainties regarding the Company’s manufacturing capabilities given its increasing preclinical and clinical commitments; and the increased risks associated with commercializing future cell-based therapeutics, including the potential for product liability claims; and other factors that are described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2008, and in its subsequent reports on Form 10-Q and Form 8-K.
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CONTACT: StemCells, Inc.
Megan Meloni
Investor Relations
650-475-3100, Ext. 105
irpr@stemcellsinc.com
Media
Tim Brons
Vida Communication, Inc.
415-675-7402
SOURCE: StemCells, Inc.
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